QBR110329

• Research type

  Research Study

• Full title

  A placebo-controlled double-blind single and repeated ascending dose study to investigate the safety and tolerability of inhaled CHF 6001 in healthy volunteers

• IRAS ID

  74058

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2010-022634-80

• Research summary

  Safety and systemic exposure of single and repeated doses of CHF6001 in healthy subjectsCHF 6001 is a novel inhalation drug being developed for the treatment of chronic obstructive pulmonary disease (COPD). It belongs to aclassof drugs currently used to treat COPD by reducing the inflammation of the airways and thus helping to alleviate symptoms of COPD. This drug will be administered for the first time in humans to assess its safety, tolerability and to find out how much of the medicine get into the blood stream and how long does the body take to get rid of it. This study consists of 2 parts: a 1st part where 2 groups of healthy male volunteers will receive a single, ascending dose of the medicine and a 2nd part where four groups of healthy male volunteers will receive the medicine for 1 week in an ascending dose setting. During part 1, each subject will stay 2 nights and 1 day at the clinical unit for 3 times or 4 times. During part 2, each subject will stay at the clinic unit for 9 nights and 8 days During the study the tolerability of the medicine will be assessed by strictly monitoring blood pressure, body temperature, heart rate, activity of the heart (12 lead ECGs and Holter ECG), lung function, blood chemistry, haematology, urynalisis and the occurrence of side effects. Blood, urine and feces samples will also be collected to find out how and how long does the body get rid of the medicine.Prior to each dose escalation the tolerability profile of the administered dose of the medicine will be carefully evaluated by a board of medical experts.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0099

• Date of REC Opinion

  25 Jul 2011

• REC opinion

  Further Information Favourable Opinion